/>iOn August 24, the US Food and Drug Administration (FDA or Agency) issued a final rule (Final Rule) that extends and clarifies the compliance dates for a limited subset of Food Safety Modernization Act (FSMA) requirements in four of the seven foundational rules part of FDA’s FSMA implementation.1 The four rules include
-
Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls (Preventive Control Rules) for Human and Animal Foods;2
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Foreign Supplier Verification Programs (FSVP);3 and
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Produce Safety.4
The Agency decided to extend the dates to address industry concerns about the practicality of complying with such dates and to better align them with the other FSMA rules. Generally, FDA granted an additional two years to comply.
The below table provides the updated compliance dates for the subset of FSMA requirements. Given the dates’ variability among the four rules, the earliest compliance date is listed.
|
FSMA Rule(s) |
Topic/Provision |
Earliest Compliance Date |
|
Preventive Control Rules |
Facilities solely engaged in packing and/or holding that produce raw agricultural commodities |
January 26, 2018 |
|
Facilities that would qualify as secondary activities farms except for the ownership of the facility |
January 26, 2018 |
|
|
Preventive Control Rule for Human Food |
Facilities that color raw agricultural commodities |
January 26, 2018 |
|
National Conference on Interstate Milk Shipments facilities producing Grade “A” milk and milk products to comply with CGMP requirements |
September 17, 2018 |
|
|
Preventive Control Rules, FSVP, and Produce Safety |
Provisions concerning customer assurances when controls are applied downstream in the distribution chain |
September 19, 2018 |
|
Preventive Control Rule for Animal Food |
Off-farm facilities solely engaged in cotton ginning that provide products without further processing for use as animal food |
May 28, 2019 |
|
FSVP |
Importation of food contact substances |
May 28, 2019 |
Amaru Sanchez contributed to this post.
1https://www.gpo.gov/fdsys/pkg/FR-2016-08-24/pdf/2016-20176.pdf
2https://www.gpo.gov/fdsys/pkg/FR-2015-09-17/pdf/2015-21920.pdf (Human Food); see also
https://www.gpo.gov/fdsys/pkg/FR-2015-09-17/pdf/2015-21921.pdf (Animal Food).
3https://www.gpo.gov/fdsys/pkg/FR-2015-11-27/pdf/2015-28158.pdf
4https://www.gpo.gov/fdsys/pkg/FR-2015-11-27/pdf/2015-28159.pdf
